Quality control in production
- Data integrity in compliance with FDA 21 CFR Part 11 and other regulations
- IQ, OQ and PQ services and software validation
- User-friendly and audit-ready systems
Quality control in production Regulatory compliance and uptime for your production processes
We support pharma quality control with precise and easy-to-use instrumentation for regulatory compliant testing of raw materials, intermediates and final products as well as process validation. All backed by comprehensive validation services, and reachable technical and application support to ensure uptime and efficiency.
Products & solutions
Norms
- USP <232>, <233>, <643>, <1057>
- Pharm. Eur. 2.4.20, 2.2.44, 2.5.33
- JP 2.59
- TOC SST according to KP
Applications
- TOC/TN analysis in cleaning validation
- TOC in ultrapure water and water for injection
- Elemental analysis by AAS, ICP-MS and ICP-OES
- Organic compounds by UV/Vis
Customer voices
Excellent user management and audit trail features
“I've been using Analytik Jena's TOC analyzers for years in pharma QC. The compliance module meets FDA 21 CFR Part 11 requirements, with excellent user management and audit trail features. I'm grateful for the trusted collaboration.”
Thomas Beinicke, Head of QC, EVER Pharma Jena GmbH
Upcoming events
E-book: compliant TOC/TN analysis in pharma
From ultrapure water testing and cleaning validation to vaccine quality control via total protein analysis - this e-book provides you with insights on how to master some of the most common TOC/TN applications in the pharmaceutical industry.
Compliance and data integrity
Our user-friendly software solutions for sum parameter analysis, elemental analysis, real-time cyclers and molecular spectroscopy are designed to achieve full data integrity while minimizing effort. Ensure fast batch approval and process validation within tight production timelines while achieving full compliance with international regulations.
Our software solutions for compliance include:
- Central data management
- Role-based user management & active directory
- Rigorous audit trail
- Electronic signatures
- Software-guided system suitability tests (SSTs) according to pharmacopoeia
In best of hands: qualification support and validation service
Get a service package tailored to pharmaceutical quality control: qualification and validation services that ensure a quick start on initial installation and compliant operation of devices and software – fully documented and audit-ready. Our modular service contracts fit your needs and our reachable expert hotline ensures that you get fast support when needed.
Applications
TOC / TN cleaning validation
The TOC/TN analyzers of the multi N/C x300 series enable TOC analysis for final rinse validation as well as swab tests, either after elution or via direct swab combustion. The multi N/C 3300 combustion devices enable trace level total nitrogen (TN) determination, while multi N/C 4300 UV minimizes cost of ownership due to the long-term warranty for the UV reactor and persulfate-free sample digestion.
Application notes
GMP Compliant TOC Cleaning Validation in Pharmaceutical Industry
GMP-Compliant TN Cleaning Validation in the Biopharmaceutical Industry
TOC testing in ultrapure water
Our solutions offer a wide dynamic linear measurement range to cover different applications within one sequence or even by the same method. This way final rinse and swab eluate samples can be processed alongside with ultrapure and sterile water or water for injection (WFI) testing. Implemented SST tests according USP, EP, JP and KP are implemented.
Application notes
TOC SST according to USP <643>
TOC performance test as per JP and KP
Total protein determination in vaccines
Catalytic combustion and chemiluminescence detection (CLD) is a compliant pharmacopoeia method for total protein determination in biopharmaceutical products like vaccines via TN analysis. Our multi N/C 2300 N analyzer can dose even smallest quantities of valuable samples from HPLC vials with a high automation degree. Via the multiWin pro software, TN readings are automatically converted into total protein results.
Application notes
Total Protein Assay in Bio-Pharmaceutical Products by TN Analysis via Catalytic Combustion
Organic and inorganic elemental contents and impurities determination
Analyze raw materials, intermediates and final products for both content and impurities. For elemental analysis in the trace resp. ultra-trace range, we offer AAS, ICP-OES and ICP-MS solutions. For molecular content, our proven photometer SPECORD PLUS series reliably determines organic compounds over a wide concentration range.
Application notes
Determination of Elemental Impurities in Pharmaceuticals by HR ICP OES
Determination of Elemental Impurities in Pharmaceuticals by ICP-MS in accordance with ICH Q3D and USP 232 and 233 using the Example of Folic Acid
Quantification of Calcium, Potassium, Magnesium and Sodium in Pharmaceutical Solutions
Products and solutions
multi N/C x300 series
- Tailored solutions for pharmaceutical TOC/TN applications
- Long-term stable and cost-effective operation
- FDA 21 CFR Part 11 Compliance module
NEW: PlasmaQuant 9200 series
- ICP-OES systems with highest resolution
- Elemental analysis in the trace range
- 21 CFR Part 11 Compliance module
PlasmaQuant MS series
- ICP-MS systems with low argon consumption
- Elemental analysis in the ultra-trace range
- FDA 21 CFR Part 11 Compliance module
AAS product range
- Robust and standard-compliant elemental analysis
- AAS with transversely heated tubes for analysis in the trace range
- 21 CFR Part 11 Compliance module
SPECORD PLUS series
- Long-term stable measurement of up to 14 samples
- Analysis of organic compounds across a wide concentration range
- Great variety of accessories
- 21 CFR Part 11 Compliance module
Downloads
Quantification of Calcium, Potassium, Magnesium and Sodium in Pharmaceutical Solutions (EN)
Open PDF
Cleaning Validation Procedures in the Pharmaceutical Industry by TOC Analysis (EN)
Open PDF
GMP-Compliant TN Cleaning Validation in the Biopharmaceutical Industry (EN)
Open PDFCleaning Validation Procedures in the Pharmaceutical Industry by TOC Analysis (EN)
Open PDF
TOC Performance Test as per Japanese and Korean Pharmacopoeia
Open PDF
Total Protein Determination in Pharmaceutical Products (Vaccines) by TNb Analysis and Catalytic Combustion (EN)
Open PDF
Determination of Elemental Impurities in Pharmaceuticals by HR-ICP-OES according to ICH Q3D and USP 232 and 233 (EN)
Open PDF
Determination of Elemental Impurities in Pharmaceuticals by ICP-MS in accordance with ICH Q3D and USP 232 and 233 using the Example of Folic Acid (EN)
Open PDF
Determination of Elemental Impurities in Sorbitol as Pharmaceutical Excipient (EN)
Open PDF
Determination of Elemental Impurities in Antibiotics according to USP 232 and 233 by HR ICP-OES (EN)
Open PDF
Detection of cell wall lacking bacterial species using the real-time PCR cycler qTOWER iris (EN)
Open PDF
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